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Recruiting NCT04616313

NCT04616313 Novel Pulmonary Imaging of Lung Structure and Function in E-cigarette Smokers

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Clinical Trial Summary
NCT ID NCT04616313
Status Recruiting
Phase
Sponsor Western University, Canada
Condition E Cigarette Use
Study Type OBSERVATIONAL
Enrollment 150 participants
Start Date 2023-01-17
Primary Completion 2027-12

Eligibility & Interventions

Sex All sexes
Min Age 16 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Hyperpolarized Xenon-129 MRI of the lungsComputed Tomography (CT)Pulmonary Function Tests (PFT)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 150 participants in total. It began in 2023-01-17 with a primary completion date of 2027-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This is a longitudinal study of the long-term health impact of e-cigarette smoking on the lungs. Participants will be followed over a period of 5 years, and impacts of e-cigarette smoking on the lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarized xenon-129 gas, pulmonary function tests, exercise capacity, computed tomography images and questionnaires.

Eligibility Criteria

Inclusion Criteria: * Written informed consent must be directly obtained from legally competent participants before any study-related assessment is performed. * Male and female participant age ≥16 years. * Participant has recently started vaping, \>1 and \<5 years weekly use. * 70 participants will be c-cigarette never users. * 70 participants will be former or current c-cigarette users. * 10 asymptomatic age and sex-matched healthy people who have never used e- or c-cigarettes will be controls. Exclusion Criteria: * Participants with contraindications for undergoing an MRI such as participants with MRI-sensitive implants, tattoos with MRI-sensitive dye and severe claustrophobia. * Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand written material. * Participant unable to perform spirometry or plethysmography maneuvers.

Contact & Investigator

Central Contact

Grace E Parraga, PhD

✉ gparraga@robarts.ca

📞 519-931-5265

Principal Investigator

Grace E Parraga

PRINCIPAL INVESTIGATOR

Western University - Robarts Research Institute

Frequently Asked Questions

Who can join the NCT04616313 clinical trial?

This trial is open to participants of all sexes, aged 16 Years or older, studying E Cigarette Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04616313 currently recruiting?

Yes, NCT04616313 is actively recruiting participants. Contact the research team at gparraga@robarts.ca for enrollment information.

Where is the NCT04616313 trial being conducted?

This trial is being conducted at London, Canada.

Who is sponsoring the NCT04616313 clinical trial?

NCT04616313 is sponsored by Western University, Canada. The principal investigator is Grace E Parraga at Western University - Robarts Research Institute. The trial plans to enroll 150 participants.

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